October-December 2018 Regulatory Update
Thursday, January 3, 2019
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These Regulatory Updates are brought to you by Michael Best & Friedrich.
This Regulatory Update includes information from October 2018 through December 2018. Please contact Seth Mailhot, Leah Ziemba, or Emily Lyons for additional information on regulatory issues that may impact upon your business.
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The October–December 2018 Regulatory Update
includes several MUST READ updates:
Click on the >>Read
More link for the complete regulatory update.
FDA AND USDA UPDATES
>>Read
More
- USDA Releases National Bioengineered Food
Disclosure Standard for Labeling of Genetically Modified Foods (MUST READ)
- FDA Issues Two Guidance Documents for Nutrition
Fact Labeling (MUST
READ)
- FDA Considers Recognizing Sesame as Allergen
- FDA Announces Qualified Health Claim for
Consuming Oils with High Levels of Oleic Acid to Reduce Coronary Heart Disease
Risk
- USDA-FSIS Announces Uniform Compliance Dates
for Food Labeling Regulations
FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES
>>Read More
- Mandatory Recall Guidance Issued (MUST READ)
- FDA Issue Two Guidance Documents on FSMA
Requirements for Produce Growers and Processors (MUST READ)
- Training Available to Meet Requirements of
Intentional Adulteration Rule (MUST READ)
OTHER DEVELOPMENTS OF INTEREST
>>Read More
- FDA Extends Comment Period on Use of Dairy Names on
Plant-Based Foods
- USDA-FSIS Issues Directive on Safe and Suitable
Ingredients used in the Production of Meat, Poultry, and Egg Products
- FDA Launches Online Training on Menu Labeling
- USDA and FDA to Jointly Regulate Cell-Cultured Food
Products
- FDA Reminds Food Companies to Obtain Third-Party
Certification to Export to China, Issues Updated Guidance
FDA AND USDA UPDATES
USDA Releases National Bioengineered Food Disclosure Standard for
Labeling of Genetically Modified Foods (MUST READ)
On Thursday, December 20, 2018, the U.S. Department
of Agriculture (USDA) released a pre-publication copy of the final rule establishing the national bioengineered (BE) food disclosure
standard. This rule is the first time
that a uniform, federal mandatory standard for the disclosure of genetically
modified (GM) foods will be implemented.
Food companies will have the option to disclose the BE content of their
foods via text, symbol, electronic or digital link, or text message.
Learn more about this final rule and what it means
for your business in Michael Best’s Client Alert.
FDA Issues Two Guidance Documents for Nutrition Fact Labeling (MUST READ)
FDA recently issues two guidance documents to
assist food manufacturers in complying with the new changes to the nutrition
labeling requirements. The first document is a final guidance that addresses the compliance date, added sugars
definition, and quantitative declarations of vitamins and minerals. The second document is a draft guidance that focuses on the serving size, Reference Amounts
Customarily Consumed (RACCs), and determining the appropriate Nutrition Facts
Panel (NFP) format, including dual-column labeling.
Reminder: Food manufacturers with $10 million or more in
annual food sale have until January 1, 2020 to convert labels to meet the new
labeling requirements, small manufacturers with less than $10 million in annual
food sales have until January 1, 2021.
FDA
Considers Recognizing Sesame as Allergen
FDA recently issued a request for information
seeking data and other information on the prevalence and severity of sesame
allergies in the U.S. and the prevalence of sesame-containing foods in the
marketplace that are not currently required to disclose the presence of sesame.
FDA will use this data to inform potential rulemaking that could require food
labels to disclose the presence of sesame as an allergen in order to protect
and promote public health. >>Learn
More
FDA
Announces Qualified Health Claim for Consuming Oils with High Levels of Oleic
Acid to Reduce Coronary Heart Disease Risk
FDA
announced
it would exercise enforcement discretion over two qualified health claims
characterizing the relationship between the reduced risk of coronary heart
disease and the consumption of oleic acid in edible oils in foods containing at
least 70% of oleic acid per serving when consumed in place of saturated
fats. To be eligible to bear the high
oleic acid edible oils and CHD qualified health claim, the high oleic acid-containing
oil must contain 5 grams of oleic acid per reference amount customarily
consumed (RACC). >>Learn
More
USDA-FSIS
Announces Uniform Compliance Dates for Food Labeling Regulations
USDA- Food Safety Inspection Service (USDA-FSIS)
has announced that January 1, 2022 as the uniform compliance date for new meat
and poultry labeling regulations that will be issued between January 1, 2019
and December 31, 2020. USDA-FSIS
announced uniform compliance dates for labeling regulations to minimize the
economic impact of label changes. >>Read
the USDA-FSIS Announcement
FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES
Mandatory Recall Guidance Issued (MUST READ)
In early November, FDA released a Question and Answer guidance document regarding situations when FDA may consider using its mandatory recall
authority. The Guidance outlines that
FDA will give the responsible party an opportunity to conduct a voluntary
recall before ordering a mandatory retail and discusses details about
situations when FDA deems a food a serious health risk necessitating the need
for a mandatory recall.
In a statement accompanying the Guidance, FDA
Commissioner Scott Gottlieb, M.D. explained that the Guidance provides
additional clarity and enables FDA to make more robust use of the mandatory
recall authority. >>Read Dr. Gottlieb’s Full Statement
FDA Issue Two Guidance Documents on FSMA Requirements for Produce
Growers and Processors (MUST READ)
FDA has issued two draft guidance documents
intended to assist produce growers and processors in complying with certain
FSMA regulations. The first document is for farms covered by the Produce Safety Rule and outlines how farms
can determine if they are eligible for exemptions from some or all of the
rule’s requirements and also provides FDA’s recommendations for satisfying
certain requirements rule. The second document is for facilities subject to FDA’s Preventive Controls for Human Food
rule that manufacture, process, pack, or
hold fresh-cut produce. The deadline for comments on both guidance documents is
April 22, 2019
Training Available to Meet Requirements of Intentional Adulteration Rule
(MUST READ)
The Food Safety Preventive Controls Alliance
recently announced the release of the online course "Conducting Vulnerability Assessments Using Key Activity Types.” This course satisfies the training
requirement in the Mitigation Strategies to Protect Food Against Intentional
Adulteration final rule to conduct a vulnerability assessment if using the Key
Activity Types method. Facilities not
exempt from the rule must comply with this FSMA regulation by July 26, 2019,
while small facilities, a business employing fewer than 500 employees, have
until July 26, 2021 to comply.
OTHER DEVELOPMENTS OF INTEREST
FDA Extends Comment Period on Use of
Dairy Names on Plant-Based Foods
FDA has extended
the comment period on the use of dairy terms such as "milk,” "yogurt,” and
"cheese” on plant-based foods and beverages until January 28, 2019. >>Comment Here
USDA-FSIS
Issues Directive on Safe and Suitable Ingredients used in the Production of
Meat, Poultry, and Egg Products
In early December, USDA-FSIS issued an
updated list of substances that may be used in the production of meat, poultry,
and egg products. >>Learn
More
FDA Launches Online Training on Menu
Labeling
Recently, FDA
released an online education module to help industry, regulatory, and consumers understand
the new menu labeling regulations. This
online training describes what types of establishments and types of foods are
covered by the menu labeling regulations and how to comply with the
regulations. FDA also published two fact sheets for industry on menu labeling and declaring calories.
USDA and FDA to Jointly Regulate Cell-Cultured Food Products
Following a public meeting, FDA and USDA announced that both agencies will jointly oversee the production of cell-cultured
food products derived from livestock and poultry. FDA will oversee cell collation, cell banks,
and cell growth and differentiation, while USDA oversees oversee the production
and labeling of food products derived from the cells of livestock and
poultry.
FDA Reminds Food Companies to Obtain Third-Party Certification to Export
to China, Issues Updated Guidance
China requires U.S. dairy, seafood, and infant
formula exporters to obtain a third-party certification to verify compliance
with Chinese laws and regulations and to update its information on the Food and
Drug Administration’s list of eligible exporters to China. Dairy, sea food, and
infant formula companies shipping products to China must take these steps by
June 15, 2019, to remain eligible exporters. FDA also released updated guidance on these requirements that clarifies how to apply electronically and update list data, and lists products that are exempt from the certification
requirements.
*Federal agencies accept public comments from
interested stakeholders even if a comment period has closed.
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